The goal of this clinical trial is to learn if ADC drug MC002 works to treat locally advanced/metastatic solid tumors in adults. It will also learn about the safety of MC002. The main questions it aims to answer are: Does participants tolerate the drug MC002 ? What medical problems do participants have when treating with MC002? Does participants benefit from the MC002 . Participants will: Intravenous infusion MC002 every 3 weeks in clinical Visit the clinic once every 3 weeks for checkups and tests Keep a diary of their symptoms
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
143
MC002 is a recombinant antibody-drug conjugate targeting the oncofetal antigen.A complete treatment cycle is defined as 21 calendar days. MC002 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle
To assess the Number of patients with Adverse Events (AE)
Any medical event in a participant which may or may not have a causal relationship with this treatment.
Time frame: From enrollmenFrom enrollment until 28 days after last study drug t to the safety follow up
Determination of MTD or RP2D
Maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of MC002
Time frame: From enrollment until 28 days after last study drug
Maximum concentration (Cmax)
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Cmax will be derived).
Time frame: From enrollment until 28 days after last study drug
ADA
Incidence, onset time, and titer of ADAs against MC002
Time frame: From enrollment until 28 after last study drug
The time taken to reach the maximum concentration (Tmax)
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Tmax will be derived).
Time frame: From enrollment until 28 days after last study drug
Area Under Curve (AUC)
PK endpoint
Time frame: From enrollment until 28 days after last study drug
Half life (T1/2)
Half life (T1/2)
Time frame: From enrollment until 28 days after last study drug
Trough concentration (Cmin)
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Cmin will be derived)
Time frame: From enrollment until 28 days after last study drug
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